Methods of dynamic annuloplasty ring sizing

ABSTRACT

A dynamic, adjustable annuloplasty ring sizer can include an adjustable ring replica, which can be adjusted through a range of sizes corresponding to available prosthetic annuloplasty repair ring sizes. Actuation of an adjustment trigger on a handle portion of the ring sizer can displace tension wires that extend through a malleable shaft and through a plurality of articulating segments that form the ring replica. Displacement of the tension wires causes flexion of the joints between adjacent articulating segments, thereby reducing the overall size of the ring replica. Releasing the tension wires can allow an elastic extension wire to act on the ring replica, enlarging the ring replica to its maximum, at-rest size. In this manner, the appropriate size of annuloplasty ring prosthesis can be determined with a single device, without requiring a plurality of static ring sizers that require individual insertion and placement for the conventional trial-and-error sizing methods.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/867,992, filed Sep. 28, 2015, which is a continuation ofU.S. patent application Ser. No. 14/187,084, filed Feb. 21, 2014 and nowissued as U.S. Pat. No. 9,149,360, which claims the benefit of U.S.Patent Application No. 61/778,086, filed Mar. 12, 2013, the disclosuresof which are expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices andparticularly to a dynamic annuloplasty ring sizer and methods of use.

BACKGROUND OF THE INVENTION

In vertebrate animals, the heart is a hollow muscular organ having fourpumping chambers: the left and right atria and the left and rightventricles, each provided with its own one-way valve. The native heartvalves are identified as the aortic, mitral (or bicuspid), tricuspid,and pulmonary, and each is mounted in an annulus comprising densefibrous rings attached either directly or indirectly to the atrial andventricular muscle fibers. Each annulus defines a flow orifice. FIG. 1shows a schematic representation of the anatomic orientation of theheart, illustrating the atrioventricular (AV) junctions within the heartand the body in the left anterior oblique projection. The body is viewedin the upright position and has three orthogonal axes:superior-inferior, posterior-anterior, and right-left.

FIG. 2 is a cutaway view of the heart from the front, or anterior,perspective, with most of the primary structures marked. As is wellknown, the pathway of blood in the heart is from the right atrium to theright ventricle through the tricuspid valve, to and from the lungs, andfrom the left atrium to the left ventricle through the mitral valve. Thepresent application has particular relevance to the repair of the mitralvalve, which regulates blood flow between the left atrium and leftventricle, although certain aspects may apply to repair of other of theheart valves. The tricuspid and mitral valves together define the AVjunctions.

Heart valve disease is a widespread condition in which one or more ofthe valves of the heart fails to function properly. Diseased heartvalves may be categorized as either stenotic, wherein the valve does notopen sufficiently to allow adequate forward flow of blood through thevalve, and/or incompetent, wherein the valve does not close completely,causing excessive backward flow of blood through the valve when thevalve is closed (regurgitation). Valve disease can be severelydebilitating and even fatal if left untreated.

Various surgical techniques may be used to repair a diseased or damagedvalve. In a valve replacement operation, the damaged leaflets areexcised and the annulus sculpted to receive a replacement valve. Anotherless drastic method for treating defective valves is through repair orreconstruction, which is typically used on minimally calcified valves.One repair technique is remodeling annuloplasty, in which the deformedvalve annulus is reshaped by attaching a prosthetic annuloplasty repairsegment or ring to the valve annulus. The annuloplasty ring is designedto support the functional changes that occur during the cardiac cycle:maintaining coaptation of the valve leaflets and valve integrity toprevent reverse flow while permitting good hemodynamics during forwardflow. Annuloplasty ring repair is currently performed on both mitral andtricuspid valves, through both traditional surgical procedures as wellas minimally invasive approaches.

An annuloplasty ring typically comprises an inner substrate of a metalsuch as rods or bands of stainless steel or titanium, or a flexiblematerial such as silicone rubber or Dacron cordage, covered with abiocompatible fabric or cloth to allow the ring to be sutured to thefibrous annulus tissue. Annuloplasty rings may be stiff or flexible,split or continuous, and may have a variety of shapes, includingcircular, D-shaped, C-shaped, or kidney-shaped. Examples are seen inU.S. Pat. Nos. 5,041,130, 5,104,407, 5,201,880, 5,258,021, 5,607,471,6,187,040, and 6,908,482. Annuloplasty rings are available in a varietyof different sizes to accommodate differences in the sizes of patients'native valves. The correct size of prosthetic annuloplasty ring to usefor a given patient must be determined for each repair procedureperformed.

To perform successful valve replacement or annuloplasty surgeries, thesize of the valve annulus must be accurately measured. In conventionalmethods, sizing may be achieved by measuring the width and height of theanterior leaflet of the mitral valve, for example, by using a valvesizer or template, which resembles the shape of the annulus and isprovided in various incremental sizes corresponding to the stepped valveor repair ring sizes. In order to use a sizing template, a surgeon orother user estimates the valve annulus size and selects the templateaccordingly. The template is guided into proximity of the annulus with ahandle. If the template is judged to be the incorrect size, it iswithdrawn, and replaced by a different template. Once the size of theannulus has been determined, a properly sized valve or annuloplastyrepair ring is selected and implanted.

Thus, during a heart valve repair procedure, the size of a patient'snative heart valve annulus is typically determined by holding varioussizers adjacent the native annulus, where each of the various sizersrepresents an available prosthetic repair ring device size. The surgeonthen determines which of the sizers is closest to the patient's nativeannulus, generally with a best guess visual determination of which sizerlooks “correct.” A surgeon typically must try several different sizers,sometimes more than once, and perhaps even test one or more repair ringsizes before being able to determine the correct repair ring size for agiven patient. This trial-and-error sizing technique is imprecise,tedious, and time-consuming. Furthermore, the surgical field may becluttered with several different static sizers.

Less invasive annuloplasty procedures have been developed in recentyears, but traditional annuloplasty and valve sizing and holdinginstruments are designed for use with open-chest surgery that exposesthe implant site. Currently, sizers are dimensionally the same as therepair rings they represent. Because of this, it can be difficult toinsert the sizers through minimally invasive surgical incisions, such asthoracotomies. Inserting several sizers, one at a time, through a smallincision can be particularly time-consuming and frustrating forsurgeons.

Thus, for these and other reasons, there remains a need for an improvedsizer and method of sizing a patient's valve annulus for annuloplastyrepair.

SUMMARY OF THE INVENTION

It is desirable to have a single, adjustable sizer that could be used toquickly and accurately determine the appropriate repair ring size for agiven patient's heart through a minimally sized incision. Adjustablesizers according to the present disclosure can be collapsible andadjustable through the entire range of repair ring device sizes anddisplay the selected size on the handle of the device. Disclosedembodiments of a ring sizer can allow for determination of theappropriate size of prosthetic annuloplasty ring without needingmultiple ring sizers, and without needing to insert and withdrawmultiple ring sizers through a minimally invasive entry. Disclosedembodiments of adjustable ring sizers can thus reduce thetrial-and-error nature of repair ring sizing techniques, as well asreduce clutter in the surgical field, and reduce the time required forsurgery and/or bypass. Some embodiments of an adjustable ring sizer canbe collapsible for insertion through a small incision as part of aminimally invasive surgical procedure.

Disclosed embodiments of such a ring sizer can generally include adynamic, adjustable ring replica at the distal end of the ring sizer,with the ring replica being adjustable through a range of sizescorresponding to available prosthetic device sizes. A user can thusdetermine the appropriate size of, for example, an annuloplasty ring fora particular patient or procedure using a single device, by manipulatingthe handle to adjust the size of the adjustable ring replica until theappropriate size is determined.

For example, in one particular embodiment, an adjustable annuloplastyring sizer can include a device body having a proximal end and a distalend, a handle portion positioned adjacent the proximal end of the devicebody, an adjustable annuloplasty ring replica positioned adjacent thedistal end of the device body, and a shaft that couples the adjustablering replica to the handle portion of the ring sizer device body. Theadjustable ring replica can be configured to be adjusted to a pluralityof different sizes. In some embodiments, the shaft is a malleable shaftcomprising a hollow bore configured to receive at least one elongatedmember configured to adjust the adjustable ring replica to a pluralityof different sizes. For example, the shaft can be configured to receiveone or more wires or cables that extend from the handle portion to theadjustable ring replica. Manipulation of the handle portion can in turnadjust the size of the adjustable ring replica by virtue of theelongated members (which can be, for example, sutures, wires, braidedcables, and/or wire rope).

In some embodiments, the handle portion can include an adjustmenttrigger, and actuation of the adjustment trigger can be configured toexpand and contract the adjustable ring replica. For example, actuationof the adjustment trigger can be configured to displace or release atleast one elongated member, which can in turn reduce or enlarge the sizeof the ring replica.

The adjustable ring replica can be a generally C-shaped ring replicahaving a first free end and a second free end, as well as an innersurface and an outer surface. In some embodiments, the adjustable ringreplica can comprise a plurality of articulating segments, wherein eachof the articulating segments is movable with respect to one or morerespective adjacent articulating segments. In some embodiments, theadjustable ring replica can include an elongated backbone segment havinga first backbone end and a second backbone end, wherein a plurality ofarticulating segments can be serially arranged and coupled to the firstbackbone end and extend to the first free end of the adjustable ringreplica. Likewise, a plurality of articulating segments can be seriallyarranged and coupled to the second backbone end and extend to the secondfree end of the adjustable ring replica. Thus the elongated backbonesegment can essentially serve as a central portion of the C-shaped ringreplica, and can be positioned approximately equidistant from the firstand second free ends of the ring replica. Further, the elongatedbackbone segment can be coupled to the shaft, such as by, for example,an articulating joint (e.g., a ball-and-socket joint).

The adjustable ring replica can include at least two bores, or channels,extending through the articulating segments and the elongated backbonesegment. For example, in one embodiment, the adjustable ring replica caninclude an extension wire channel and a tension wire channel. In oneembodiment, the extension wire channel can be positioned adjacent theouter surface of the adjustable ring replica and the tension wirechannel can be positioned near the center of the articulating segments,or adjacent the inner surface of the adjustable ring replica.

In some embodiments, the extension wire channel is configured to receiveat least one elongated member, which can be an elastically deformablematerial that extends from the first free end of the adjustable ringreplica to the second free end of the adjustable ring replica.Similarly, the tension wire channel can be configured to receive atleast one elongated member. In some embodiments, the tension wirechannel can be configured to receive a first elongated member extendingfrom the elongated backbone segment to the first free end of theadjustable ring replica and a second elongated member extending from theelongated backbone segment to the second free end of the adjustable ringreplica.

Displacement of the tension wires (e.g., by actuation of the adjustmenttrigger on the handle portion of the sizer) can create a moment about apivot area between adjacent articulating segments, which in turn canresult in flexion of the joint between adjacent articulating segments,thereby reducing the overall diameter of the ring replica. When tensionis released on the elongated members extending through the tension wirechannel, the extension wire (e.g., the elongated member extendingthrough the extension wire channel) can be configured to cause expansionof the ring replica back to the maximum, at-rest ring size. The ringreplica can thereby be adjusted through a range of sizes correspondingto available prosthetic annuloplasty rings. The adjustable annuloplastyring sizer can be manipulated at an implant site until the correctprosthesis size is determined, without the need to remove or insertmultiple ring sizers, as is the case with conventional methods.

One specific embodiment of a sizing device for selecting the correctrepair ring size to use in a given surgical procedure, can include ahandle portion positioned adjacent a proximal end of the device, anadjustable C-shaped ring replica positioned adjacent a distal end of thedevice, wherein the adjustable C-shaped ring replica can include a freering end and a second free ring end, a malleable shaft coupling thehandle portion to the adjustable C-shaped ring replica via anarticulating joint, the malleable shaft being configured to receive atleast one tension wire, and an adjustment trigger positioned adjacentthe handle portion, wherein actuation of the adjustment trigger can beconfigured to displace the at least one tension wire, and whereindisplacement of the at least one tension wire can be configured tocontract and/or expand the adjustable C-shaped ring replica.

Further, the C-shaped adjustable ring replica can include a backbonesegment coupled to the malleable shaft, wherein the backbone segmentincludes a first backbone end and a second backbone end opposite thefirst backbone end, wherein a first plurality of articulating segmentsserially coupled to one another extend in an elongated manner from thefirst backbone end to the first free end of the ring replica, andwherein a second plurality of articulating segments serially coupled toone another extend in an elongated manner from the second backbone endto the second free end of the ring replica. In this embodiment, theC-shaped adjustable ring replica can include an extension wire channeladjacent an outer ring surface and a tension wire channel adjacent aninner ring surface, and displacement of the at least one tension wirecan be configured to move each respective articulating segment withrespect to each adjacent articulating segment and/or the backbonesegment. In some embodiments, the ring sizer can further include adisplay on the handle portion of the device, wherein the display can beconfigured to provide the size of annuloplasty ring that corresponds toeach respective size of the adjustable ring replica. For example, if anembodiment of an adjustable ring sizer has a range of 24-40 mm, thedisplay window can be configured to read “24” or “24 mm” or the like,when the ring replica is in its contracted, minimal configuration (e.g.,when maximum tension is placed on the tension wires and the ring replicais contracted to a size that corresponds to a repair ring size of 24).Likewise, the display window can be configured to read “40” or “40 mm”or the like when the ring replica is in its expanded, maximumconfiguration (e.g., when tension is released from the tension wires andthe ring replica is allowed to expand to a size that corresponds to arepair ring size of 40). The display window can be configured to displaythe size within the range that corresponds to the present size of thering replica. Thus, the display can change through a plurality ofavailable repair ring sizes as the size of the ring replica is adjusted(e.g., expanded and contracted via manipulation of the adjustmenttrigger) between the minimum and maximum configurations.

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of the AV junctions within theheart and the body in the left anterior oblique projection.

FIG. 2 is a cutaway view of the heart from the front, or anterior,perspective.

FIG. 3 is a perspective view of one embodiment of an adjustableannuloplasty ring sizer according to the present disclosure.

FIG. 4 shows a perspective, close-up view of the adjustable ring replicashown on the adjustable annuloplasty ring sizer of FIG. 3.

FIG. 5 shows a cross section view of the adjustable ring replica of FIG.4, taken along line 5-5 in FIG. 4.

FIG. 6 shows a top plan view of one embodiment of an adjustable ringreplica, in an expanded configuration.

FIG. 7 shows a top plan view of one embodiment of an adjustable ringreplica, in a contracted configuration.

FIG. 8 is a cross-section, close-up view of a portion of FIG. 5, showingtwo articulating segments engaged with one another.

FIG. 9 is a perspective view of one embodiment of an articulatingsegment that can be used to create an adjustable annuloplasty ringreplica according to the present disclosure.

FIG. 10 is a cross-section view of the articulating segment of FIG. 9,taken along line 10-10 in FIG. 9.

FIG. 11 shows one embodiment of a backbone segment that can form acentral portion of an adjustable ring replica according to the presentdisclosure.

FIG. 12 is a cross-section view of the backbone segment of FIG. 11,taken along line 12-12 in FIG. 11.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As used in this application and in the claims, the singular forms “a,”“an,” and “the” include the plural forms unless the context clearlydictates otherwise. Additionally, the term “includes” means “comprises.”Although the operations of exemplary embodiments of the disclosed methodmay be described in a particular, sequential order for convenientpresentation, it should be understood that the disclosed embodiments canencompass an order of operations other than the particular, sequentialorder disclosed. For example, operations described sequentially may insome cases be rearranged or performed concurrently. Further,descriptions and disclosures provided in association with one particularembodiment are not limited to that embodiment, and may be applied to anyembodiment disclosed herein. Moreover, for the sake of simplicity, theattached figures may not show the various ways in which the disclosedsystem, method, and apparatus can be used in combination with othersystems, methods, and apparatuses.

Embodiments of a heart valve repair ring sizer according to the presentdisclosure advantageously can allow determination of the appropriatesize of prosthetic annuloplasty ring without needing multiple ringsizers, and without needing to insert and withdraw multiple ring sizersthrough a minimally invasive entry. Disclosed embodiments of such a ringsizer can generally include a dynamic, adjustable ring replica at thedistal end of the ring sizer, with the ring replica being adjustablethrough a range of sizes corresponding to available prosthetic devicesizes. A user can thus determine the appropriate size of annuloplastyring for a particular patient or procedure using a single device, bymanipulating the handle to adjust the size of the adjustable ringreplica until the appropriate size is determined. Such adjustable ringsizers can be used in the repair of mitral and tricuspid valves, throughboth traditional surgical exposures as well as minimally invasiveapproaches. Some embodiments of a ring replica can be collapsed to fitthrough a small surgical incision.

FIG. 3 shows one embodiment of a dynamic, adjustable ring sizer, ordevice, 100 for determining the appropriate size of prostheticannuloplasty ring to use for a particular patient. The sizer 100includes a device body 102, having a proximal end 104 and a distal end106. The device body 102 can include a handle portion 108 adjacent theproximal end 104 and an adjustable C-shaped ring replica 110 adjacentthe distal end 106. As will be explained in further detail below, theadjustable ring replica 110 can be configured to be adjusted to aplurality of different ring sizes corresponding to the available sizerange of prosthetic annuloplasty repair rings. For example, theadjustable ring replica 110 can expand and contract to larger or smalleroverall diameters. In some embodiments, the ring replica 110 can expandand contract between a maximum, at-rest diameter corresponding to a 40mm repair ring size and a minimum, contracted diameter corresponding toa 24 mm repair ring size, with the ring replica 110 being continuouslyadjustable through this range of sizes. Alternatively, in someembodiments, the adjustable ring sizer 100 can be configured so that itis adjustable in stepped increments, where each increment corresponds toan available repair ring size.

In use, the adjustable ring replica 110 can be positioned at or near animplant site (e.g., a patient's native mitral valve or tricuspid valve).Generally, manipulation of the sizer 100 can adjust the size of theadjustable ring replica 110 until the physician or other user hasdetermined the appropriate size of prosthetic annuloplasty ring for agiven procedure. A display window 101 positioned on the handle portion108 can display the annuloplasty ring size corresponding to the presentsize of the ring replica 110. For example, in some embodiments, thedisplay window 101 can be a digital display that displays a numbercorresponding to the appropriate size of annuloplasty ring determined bythe sizer 100. In other embodiments, the display window 101 can simplybe a string of numbers printed on the device that moves through thedisplay window 101 as the adjustment trigger 112 is moved back andforth. Any suitable means for displaying the corresponding annuloplastyring size can be used in connection with the present adjustable sizer;the above are meant as illustrative examples only.

In some embodiments, the display window 101 can be configured to providethe size of annuloplasty ring that corresponds to the present size ofthe adjustable ring replica 110. For example, if an embodiment of anadjustable ring sizer 100 has a ring replica size range corresponding toa repair ring size range of 24-40 mm, the display window 101 can beconfigured to read “24” or “24 mm” or the like, when the ring replica110 is in its contracted, minimal configuration (e.g., when maximumtension is placed on the tension wires and the ring replica 110 iscontracted to a size that corresponds to a repair ring size of 24).Likewise, the display window 101 can be configured to read “40” or “40mm” or the like when the ring replica 110 is in its expanded, maximumconfiguration (e.g., when tension is released from the tension wires andthe ring replica 110 is allowed to expand to a size that corresponds toa repair ring size of 40). The display window 101 can be configured todisplay the size within the range that corresponds to the present sizeof the ring replica 110. Thus, the display can change through aplurality of available repair ring sizes as the size of the ring replica110 is adjusted (e.g., expanded and contracted via manipulation of theadjustment trigger 112) between the minimum and maximum configurations.

The sizer 100 can include an adjustment trigger 112 in connection withthe handle portion 108. The adjustment trigger 112 can be configured tobe positionable or movable between a first end position and a second endposition, where movement of the adjustment trigger 112 between theseendpoints (e.g., between the first end position and second end position)can result in adjustment of the size of the adjustable ring replica 110.In some embodiments, and as shown in FIG. 3, the adjustment trigger 112can be a squeeze trigger, where the adjustment trigger 112 can be movedsimply by squeezing or pulling it towards the handle portion 108 ofsizer 100. In some embodiments, the adjustment trigger 112 can bemovable from a first end position corresponding to a maximum, at-restposition (shown in FIG. 3) to a second end position corresponding to aminimum, contracted ring replica configuration. In some embodiments, thesecond end position can be a position where the adjustment trigger 112is squeezed against the handle portion 108 of the sizer 100. Forexample, in some embodiments, the adjustment trigger can be movable froman at-rest position (shown in FIG. 3) to a position in contact with, orat least in close proximity to, the handle portion 108. Movement of theadjustment trigger 112 can be configured to adjust the size of theadjustable ring replica 110 as will be explained in further detail,below. In some embodiments, the adjustment trigger 112 can be movablethrough a continuous range of positions. In other embodiments, theadjustment trigger 112 can be movable through a series of incrementalpositions, where each position corresponds to a particular repair ringsize. In alternative embodiments, the adjustment trigger 112 can be anysuitable mechanism that can be used or configured to actuate or adjustthe size of the ring replica 110.

A shaft 114 can couple the handle portion 108 to the adjustable ringreplica 110. In some embodiments, shaft 114 is a malleable shaft thatcan allow for some flexibility. Such malleability can ease positioningof the adjustable ring replica 110 within a patient's body, especiallyfor minimally invasive procedures. In some embodiments, the shaft 114can have a hollow bore through the central axis of the shaft. The hollowbore can be configured to receive at least one elongated memberconfigured to affect adjustment of the adjustable ring replica 110 to aplurality of different sizes. For example, one or more elongated memberssuch as sutures, wire ropes, wires, and/or wire cable can pass throughthe bore of the shaft 114. In some embodiments, and as will be describedin further detail below, the elongated members can continue through theshaft and into bores in the adjustable ring replica 110. In this manner,actuation, or movement of the adjustment trigger 112 can displace atleast one elongate member, thereby contracting or expanding the size ofthe ring replica 110. For example, in one embodiment, squeezing theadjustment trigger 112 can displace a wire rope passing through theshaft 114, thereby causing contraction of the adjustable ring replica110 to a smaller size. Releasing the adjustment trigger 112 can releasetension on the elongate members, thereby allowing expansion of theadjustable ring replica 110 to a larger size. The adjustable ringreplica 110 can thus be adjusted through a range of different sizescorresponding to available prosthetic annuloplasty ring sizes, bysqueezing and releasing the adjustment trigger 112 until the appropriatesize has been determined. In embodiments where the adjustable ringreplica 110 is incrementally adjusted, the adjustable sizer 100 caninclude, for example, a ratcheting mechanism to incrementally contractthe size of the adjustable ring replica 110. These embodiments can alsoinclude a release mechanism to allow expansion of the ring replica 110to larger sizes.

The adjustable ring replica 110 can be generally C-shaped, with a firstfree end 116 and a second free end 118. As the size of the ring replica110 is adjusted, the first and second free ends 116, 118 can beconfigured to move closer together and farther apart as the ring replica110 is adjusted to smaller and larger sizes, respectively. As best seenin FIG. 4, the ring replica 110 can have an inner ring surface 120defined by the interior of the C-shape, and an outer ring surface 122defined by an exterior of the C-shape.

In some embodiments, the adjustable ring replica 110 can include anumber of different individual pieces that can move with respect to oneanother, thereby allowing adjustment of the ring replica's size. In onespecific embodiment, the adjustable ring replica 110 can include acentrally located, elongated, curved backbone segment 124 and aplurality of articulating segments 130 extending from a first backboneend 126 and a second backbone end 128 towards the first free 116 and thesecond free end 118, respectively, of the ring replica 110. Thus, aplurality of articulating segments 130 can be serially arranged andcoupled to one another and extend in an elongated manner from the firstbackbone end 126 to the first free end 116 of the ring replica 110.Similarly, a plurality of articulating segments 130 can be seriallyarranged and coupled to one another and extend in an elongated mannerfrom the second backbone end 128 to the second free end 118 of the ringreplica 110. Thus, the backbone segment 124 can be positioned as acentral portion of the ring replica 110, being positioned approximatelyequidistant from the first and second free ends 116, 118 of ring replica110.

The articulating segments 130 can be configured to engage with one ormore adjacent articulating segment(s) 130 and/or the backbone segment124. The articulating segments 130 can be configured such that when theyare engaged with each other and the backbone segment 124, they formarcs, or curved segments, extending from the first and second backboneends 126, 128. The articulating segments 130 can be movable with respectto one another, and with respect to the backbone segment 124. In thismanner, an adjustable ring replica 110 is formed, whereby movement ofthe articulating segments 130 can effectively adjust the overall size ofthe ring replica 110 to determine the best size of annuloplasty ring fora particular patient or procedure.

The adjustable ring replica 110 can be coupled to the malleable shaft114 in order to allow manipulation of the handle portion 108 to adjustthe size of the ring replica 110. In some embodiments, the ring replica110 can be coupled to the shaft 114 via an articulating joint 132.Articulating joint 132 can be, for example, a ball and socket joint thatcan be configured to allow a low-friction, full range of motion of thering replica 110 with respect to the shaft 114. Articulating joint 132can be configured to allow the ring replica 110 to pivot in alldirections with respect to the shaft 114, in order to allow properpositioning of the ring replica when in use in vivo. In the specificembodiment shown in FIG. 4, the articulating joint 132 can be composedof a socket 134 positioned adjacent the distal end of shaft 114 and aball portion 136 which can be coupled to the backbone segment 124, suchas by joint connection 138. In some embodiments, joint connection 138and ball portion 136 can be formed of an integral body, with the jointconnection 138 coupled to the backbone segment 124, such as by screws orother fasteners. In other embodiments, articulating joint 132 can be anyother suitable joint that can provide enough range of motion to allowproper positioning of the ring replica 110 when the adjustable ringsizer 100 is in use.

In some embodiments, adjustment of the size of the ring replica 110(e.g., manipulation of the articulating segments 130) can be providedvia one or more elongated members that pass through the shaft 114 aswell as through channels in the backbone segment 124 and articulatingsegments 130. As best seen in FIG. 5, which shows a cutawaycross-section view of the ring replica 110 shown in FIGS. 3-4, someembodiments of a ring replica 110 can include two bores, or channels140, 142, to receive such elongated members. As shown in FIG. 5, thechannels 140, 142 can extend essentially continuously from the firstfree end 116 to the second free end 118 of the ring replica 110. Thechannels 140, 142 can be hollow bores that extend through the interior,along the longitudinal axis of the elongated backbone segment 124 (seelongitudinal axis L2 in FIG. 11) as well as each of the articulatingsegments 130 (see longitudinal axis L1 in FIG. 9), thereby beingconfigured to receive one or more elongated members. In someconfigurations of the ring replica 110, small gaps, or spaces 144 mayform between adjacent articulating segments 130 or between anarticulating segment 130 and the backbone segment 124. Elongated membersthat pass through the channels 140, 142 can simply extend across thesegaps 144, and continue on through the respective channel 140, 142 in thenext adjacent articulating segment 130. One or more of the elongatedmembers can extend through one or more of the channels 140, 142 from thefirst free end 116 to the second free end 118 of the ring replica 110.

In some embodiments, the ring replica 110 can have an extension wirechannel 140 positioned adjacent the outer surface 122 of the ringreplica 110, and a tension wire channel 142 positioned adjacent theinner surface 120 of the ring replica 110. In some embodiments,elongated members (e.g., sutures, wire rope, or wire cable) that passthrough the extension wire channel 140 and tension wire channel 142 caneffectively hold together the backbone segment 124 and the articulatingsegments 130 to form the ring replica, without the need for fasteners oradhesives joining adjacent articulating segments 130, thereby allowingfor a flexible configuration, and movement of the articulating segments130 with respect to one another.

The extension wire channel 140 can be configured to receive a singleelongated member, or extension wire (see, e.g., extension wire 146 inFIG. 6), that extends from the first free end 116 to the second free end118 of the ring replica 110. The extension wire can extend through theextension wire channel 140 of each articulating segment 130 and thebackbone segment 124, spanning the gaps or spaces 144. The extensionwire can be any elastically deformable material that can impart at leasta minimal bending stiffness to the ring replica 110. In someembodiments, the extension wire can be a flexible wire, such as aNitinol wire. The extension wire can be configured to have enoughstiffness to give an initial, at-rest shape to the ring replica 110(e.g., the shape of the ring replica 110 corresponding to its largestsize in the adjustment range), yet flexible enough to allow contractionor compression of the ring replica 110 (e.g., reduction in the overalldiameter of the ring replica 110, through the range of sizes) inresponse to action on the tension wires. The extension wire can beconfigured to provide a bias or shape-memory properties, such that whentension is placed on the tension wires, the ring replica 110 can beadjusted to smaller sizes and when tension is released from the tensionwires, the extension wire can force the ring replica 110 back to themaximum, at-rest ring size.

While the extension wire is typically a single, elongated wire member,the tension wire channel 142 (typically positioned adjacent the innersurface 120 of ring replica 110) can be configured to receive twoelongated members, or tension wires. A first tension wire can extendfrom the backbone segment 124 to the first free end 116 of the ringreplica 110, and a second tension wire can extend from the backbonesegment 124 to the second free end 118 of the ring replica 110. Applyingtension to the tension wires (such as via displacing them bymanipulating or actuating the adjustment trigger 112 of handle portion108 (see FIG. 3)) can exert force on the articulating segments 130,moving them with respect to one another, and bringing the first andsecond free ends 116, 118 of ring replica 110 closer together, toeffectively reduce the size of the ring replica 110. In this manner, thering replica 110 is adjustable through a range of sizes and can bevaried continuously or incrementally from a maximum, at-rest sizeimparted by the extension wire, to a minimum, contracted size when actedon by the tension wires.

The tension wires can be, for example, a flexible wire rope, a wirecable, a braided wire cable, sutures, strings, or any material withsufficient flexibility and tensile strength to allow for adjustment ofthe ring replica 110 according to the present disclosure. In someembodiments, the tension wires can have low bending stiffness but hightensile strength. The tension wires can be flexible, thereby allowingmovement of the articulating segments 130 with respect to one another.In one specific embodiment, the tension wires can be, for example,stainless steel wire rope.

In some embodiments, each of the articulating segments 130 can beidentical to one another. In other embodiments, one or more of thearticulating segments 130 can be slightly different from each of theother articulating segments 130. For example, in some embodiments of anadjustable ring sizer, having the tension channel 142 in a slightlydifferent location from segment to segment can change the lever armsacting on the respective articulating segments 130, and therefore theamount of actuation for a respective articulating segment for a givenchange in tension in the tension wire. This can allow the shape of thering replica 110 to change as the ring size is adjusted.

FIGS. 6 and 7, which are not drawn to scale, show one example of therelative range of sizes for one embodiment of an adjustable ring replica110 according to the present disclosure. The ring replica 110 is shownin an at-rest, maximum ring size in FIG. 6, having a maximum diameter ofd_(max), and is shown in a smaller ring size in FIG. 7, having a maximumdiameter of d_(min), where d_(min) is smaller than d_(max). The ringreplica 110 can be adjustable continuously or incrementally between themaximum and minimum ring sizes, to allow a physician or other user toadjust the ring replica 110 to a plurality of ring sizes correspondingto available annuloplasty repair ring sizes, in order to best determinethe appropriate annuloplasty ring prosthesis to use for a particularpatient or procedure. Relaxing the tension wires can allow the ringreplica 110 to expand to the enlarged configuration shown in FIG. 6,while tensioning the tension wires can force the ring replica 110 to becontracted to the smaller configuration shown in FIG. 7.

In the embodiment shown in FIGS. 6 and 7, an adjustable ring replica 110is formed from a backbone segment 124 having a first backbone end 126and a second backbone end 128. A plurality of articulating segments 130engage with one another and extend serially from the first backbone end126 to the first free end 116 of the ring replica 110. Similarly, aplurality of articulating segments 130 engage with one another andextend serially from the second backbone end 128 to the second free end118 of the ring replica 110. An extension wire channel 140 (showndashed) extends through the backbone segment 124 and each articulatingsegment 130, adjacent the outer surface 122 of the ring replica 110. Theextension wire channel 140 is configured to receive an elongated member,extension wire 146, which extends from the first free end 116 to thesecond free end 118 of the ring replica 110. The extension wire 146 canbe secured in any suitable manner so that it remains in place within theextension wire channel 140. For example, in some embodiments, the endsof the extension wire 146 can be fastened or adhered to the first andsecond free ends 116, 118, respectively of the ring replica 110, such asby welding, adhesives, or some other fastener. In some embodiments, theends of the extension wire can simply be enlarged, knotted, twisted,bent, or otherwise secured so that the extension wire 146 cannot bepulled through the extension wire channel 140. For clarity, FIGS. 6 and7 show the articulating segments 130 and backbone segment 124 intransparent material so that extension wire 146 is visible throughoutthe ring replica 110.

A tension wire channel 142 (shown dashed) extends through the backbonesegment 124 and each articulating segment 130, adjacent the innersurface 120 of the ring replica 110. The tension wire channel 142 isconfigured to receive one or more elongated members, such as tensionwires 148, 150. Tension wire 148 extends through the tension channel 142from the first free end 116 of the ring replica 110, through a pluralityof articulating segments 130, through a portion of the backbone segment124, and further through the malleable shaft and handle portion of theadjustable ring sizer (although for clarity, the tension wires 148, 150are not drawn inside the tension channel 142, and are shown capped inFIGS. 6 and 7). Similarly, tension wire 150 extends through the tensionchannel 142 from the second free end 118 of the ring replica 110,through a plurality of articulating segments 130, through a portion ofthe backbone segment 124, and further through the malleable shaft andhandle portion of the adjustable ring sizer. The extension wire 146 andtension wires 148, 150, span any gaps 144 between adjacent articulatingsegments 130 and/or between the backbone segment 124 and adjacentarticulating segments 130.

The extension wire 146 runs through the outer extension channel 140 andcan be configured to hold the ring replica 110 at the maximum ring size(e.g., d_(max) shown in FIG. 6) when there is no tension on the tensionwires 148, 150. The tension wires 148, 150 (e.g., flexible wire ropecables) run through the inner tension wire channel 142. Tensioning thetension wires 148, 150 (e.g., by pressing or squeezing the adjustmenttrigger 112 on handle portion 108 shown in FIG. 3) creates a momentabout a pivot area, which in turn causes flexion of the joint formed byadjacent articulating segments 130. Each articulating segment can have amale and female articulating area that act as a hinge and allow the twosegments to flex (e.g., applying tension to the tension wires 148, 150can cause adjacent articulating segments to articulate at the pivot areaformed where respective male and female articulating areas of adjacentarticulating segments interface with one another).

FIG. 8 shows a close-up, cross-section view of such a joint 151 formedby two adjacent articulating segments 130 a, 130 b. As shown in FIG. 8,adjacent articulating segments 130 a, 130 b, engage with one anothersuch that a pivot area is formed at the interface between a pivotingprojection 152 b (male articulating area) of articulating segment 130 band a receiving area 160 a (female articulating area) of articulatingsegment 130 a. The pivoting projection 152 b can be inserted intoreceiving space 160 a formed by a pair of receiving surfaces 154 a(receiving space 160 is best seen in FIG. 9; only one receiving surface154 a is visible in FIG. 8). A pivot surface 156 b of articulatingsegment 130 b can engage with and pivot against pivot face 158 a ofarticulating segment 130 a. Tensioning the tension wires (which are notshown in FIG. 8, but would extend through tension wire channel 142,(e.g., the portions 142 a, 142 b, of tension wire channel 142 thatextend through articulating segments 130 a, 130 b, respectively) createsa moment about the pivot area that in turn causes flexion of the joint151 (e.g., movement of articulating segments 130 a, 130 b with respectto one another that increases or decreases the size of gap 144). As thearticulating segments 130 a, 130 b, move with respect to one another,the pivot surface 156 b pivots against pivot face 158 a, and thepivoting projection 152 b can move within the receiving space 160 a(e.g., against receiving surfaces 154 a). The degree of flexion of thejoint 151 is related to the amount of tension (e.g., displacement)placed on the tension wires in the tension channel 142. As described inmore detail above, one tension wire can extend through each half of thering replica, and each of the two tension wires can extend through aportion of the backbone segment, through the malleable shaft, and canterminate at the trigger mechanism in the handle. Actuation of theadjustment trigger can cause a displacement of the tension wires andtherefore actuation between each of the articulating segments 130 (e.g.,articulating segments 130 a, 130 b) of a ring replica.

Turning now to a single articulating segment 130, FIG. 9 shows aperspective view of a single articulating segment 130, and FIG. 10 showsa cut-away perspective view of the articulating segment 130 of FIG. 9.Extension wire channel 140 is visible, adjacent to the outer surface 122of the ring replica, and tension wire channel 142 is positioned adjacentto the inner surface 120 of the ring replica. A pivoting projection 152can be positioned at one end of the articulating segment, and areceiving space 160 can be positioned at the opposite end of thearticulating segment, the receiving space 160 being defined by a firstand second receiving surface 154. Thus, the pivoting projection 152 canbe configured to engage with the receiving space of a first adjacentarticulating segment and similarly, the receiving space 160 can beconfigured to receive a pivoting projection from a second adjacentarticulating segment. Each pivoting projection 152 can include a pivotsurface 156 which can be configured to pivot against the pivot face 158within the receiving space 160 (see FIG. 10). In this manner, whentension is placed on the tension wires within the tension channel 140,flexion between adjacent articulating segments 130 can be created viathe pivoting projection 152 moving against the receiving face 158 andreceiving surfaces 154 within the receiving space 160.

The articulating segments 130 can be composed of any suitable materialthat can be configured as described above. In some embodiments, thearticulating segments can be formed of a molded polymer such aspolycarbonate or ABS.

In some embodiments, each articulating segment of the ring replica canbe identical in a given sizer device. In other embodiments, the relativelocations of the tension wire channel and the pivot area can be adjustedfrom segment to segment to control how the shape of the ring replicachanges as it is adjusted from the largest to the smallest size. Thiscan accommodate changes in shape of the repair rings as the sizechanges, such as with the commercially available Carpentier-EdwardsPhysio II Annuloplasty Ring for mitral valve repair (EdwardsLifesciences Corp, Irvine, Calif.), which evolves from the nativeD-shape to a more circular shape as the repair ring size increases from24 to 40, to accommodate the pathological changes in mitral annulardimensions. To accommodate these changes, in some embodiments of anadjustable ring sizer, having the tension channel in a slightlydifferent location relative to the pivot area from segment to segmentcan change the lever arms accordingly, and therefore the amount ofactuation for a respective articulating segment for a given change intension in the tension wire. This can allow the shape of the ringreplica to change as the size is adjusted.

FIGS. 11 and 12 show a perspective view and a cut-away view of backbonesegment 124, respectively. In contrast to the embodiment of thearticulating segment 130 shown in FIGS. 9 and 10, the backbone segment124 of FIGS. 11 and 12 can be symmetrical, with both the first backboneend 126 and the second backbone end 128 having receiving spaces 166,168, respectively. Each receiving space 166, 168 can be defined byopposing receiving surfaces 170 and a receiving face 172. The first andsecond receiving spaces 166, 168 can be configured to receive respectivepivoting projections from a first and second articulating segment thatengage with the backbone segment 124, such that the pivot surface of thepivoting projection of each respective adjacent articulating segmentengages with the respective receiving face 172 of the backbone segment124.

An extension wire (not shown, for clarity) can extend through theextension channel 140 adjacent the outer surface 122 of the ringreplica. A first and second tension wire (not shown, for clarity) canextend through approximately half of the ring replica. Each tension wirecan extend through a portion of the tension wire channel 142 adjacentthe inner surface 120 of the backbone segment 124 and through thetension wire channel of a plurality of articulating segments (e.g., eachtension wire can extend through the tension wire channel of half of thearticulating segments, as each tension wire extends through a portion ofthe backbone segment to one free end of the ring replica). When tensionis placed on the tension wire, a moment is created about the pivot areaswhere pivoting projections of adjacent articulating segments interfacewith the receiving spaces 166, 168 of the backbone segment, therebycausing flexion (e.g., movement of the articulating segments withrespect to the backbone segment 124). In this manner, tension on thetension wires can adjust the ring size of the ring replica.

Backbone segment 124 can also include first and second tension wireentrance bores 162, 164 (FIG. 11). The entrance bores 162, 164 can beconfigured to receive a first and second tension wire. In someembodiments of a dynamically adjustable ring sizer according to thepresent disclosure, each respective tension wire can extend through amalleable shaft coupling the handle portion to the ring replica, throughthe respective first or second entrance bores 162, 164, and into aportion of the tension channel 142 of backbone segment 124. The firsttension wire can extend through the first entrance bore 162, through aportion of the tension wire channel 142 towards the first backbone end126, and then through each of a plurality of serially arrangedarticulating segments to the first free end of the ring replica.Similarly, the second tension wire can extend through the secondentrance bore 164, through a portion of the tension wire channel 142towards the second backbone end 128, and then through each of aplurality of serially arranged articulating segments to the second freeend of the ring replica.

As with the articulating segments, the backbone segment 124 can becomposed of any suitable material that can be configured as describedabove. In some embodiments, the backbone segment can be formed of amolded polymer such as polycarbonate or ABS.

Presently disclosed embodiments of an adjustable ring sizer can provideseveral advantages over conventional repair ring sizers. For example, insome embodiments, the adjustability of the present dynamic ring sizerscan allow a single sizing device to cover the entire range of availablerepair rings. By contrast, in conventional methods, one would work withseveral different static ring sizers, one static sizer corresponding toeach available size of repair ring. In some embodiments, the use of asingle adjustable sizer according to the present disclosure (instead ofmultiple, static sizers) can reduce clutter in the operating field, makesizing the patient's annulus quicker, and/or reduce bypass time duringrepair procedures.

Furthermore, some embodiments of an adjustable ring sizer according tothe present disclosure can be configured to collapse, therebyfacilitating minimally invasive surgical procedures, which are performedthrough small surgical incisions. By contrast, conventional staticsizers can be too large to fit through a minimally invasive surgicalincision.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims. I thereforeclaim as my invention all that comes within the scope and spirit ofthese claims.

What is claimed is:
 1. A method for sizing a heart valve annulus,comprising: preparing a sizing device including a proximal handle havingan actuator, a shaft coupled to and extending in a distal direction fromthe handle, a generally C-shaped annuloplasty ring replica having afirst free end and a second free end and coupled to a distal end of theshaft configured to be adjusted to a plurality of different ring sizes,wherein the annuloplasty ring replica is elongated and defines a shapeof the annulus being sized and is biased to a maximum ring size, whereinthe shaft has a hollow bore, and wherein the sizing device furtherincludes at least one flexible tension member coupled to the actuator inthe handle that passes through the hollow bore that extends along theshaft and then through aligned channels in a plurality of articulatingsegments defining an arc of the annuloplasty ring replica, whereintension on the flexible tension member pivots the articulating segmentswith respect to one another to reduce the ring size of the annuloplastyring replica to a plurality of different ring sizes smaller than themaximum ring size; reducing the size of the adjustable ring replica toless than the maximum ring size using the actuator; positioning theadjustable ring replica at or near a patient's native mitral valve ortricuspid valve annulus; increasing the ring size of the adjustable ringreplica using the actuator until an outer surface contacts the valveannulus; and determining an appropriate ring size of prostheticannuloplasty ring for the valve annulus.
 2. The method according toclaim 1, wherein the annuloplasty ring replica comprises a backbonesegment coupled to the shaft including a first backbone end and a secondbackbone end opposite the first backbone end, wherein a first pluralityof the articulating segments serially coupled to one another extend inan elongated manner from the first backbone end to the first free end ofthe annuloplasty ring replica, and wherein a second plurality of thearticulating segments serially coupled to one another extend in anelongated manner from the second backbone end to the second free end ofthe annuloplasty ring replica.
 3. The method according to claim 1,wherein the annuloplasty ring replica further includes a plurality ofaligned extension wire channels in a plurality of articulating segmentsand a flexible extension wire extending therethrough that biases theannuloplasty ring replica to the maximum ring size, wherein tension onthe flexible tension wire reduces the ring size of the annuloplasty ringreplica against the bias of the flexible extension wire.
 4. The methodaccording to claim 1, wherein the shaft is malleable and couples to theannuloplasty ring replica with a swivel joint, and the step ofpositioning includes bending the handle and/or re-orienting theannuloplasty ring replica relative to the handle.
 5. The methodaccording to claim 1, further comprising a display on the handleconfigured to provide the ring size of annuloplasty ring thatcorresponds to incremental ring sizes of the annuloplasty ring replica,wherein the step of determining includes observing the display when theadjustable ring replica contacts the valve annulus.
 6. The methodaccording to claim 1, wherein a proportional shape of the annuloplastyring replica also changes for different ring sizes.
 7. The methodaccording to claim 6, wherein the annuloplasty ring replica is moreD-shaped for smaller ring sizes and more circular for larger ring sizes.8. A method for sizing a heart valve annulus, comprising: preparing asizing device including a proximal handle having an actuator, a shaftcoupled to and extending in a distal direction from the handle, agenerally C-shaped annuloplasty ring replica having a first free end anda second free end and coupled to a distal end of the shaft configured tobe adjusted to a plurality of different ring sizes, the annuloplastyring replica comprising a plurality of articulating segments defining anarc of the annuloplasty ring replica and each segment being pivotablewith respect to one or more respective adjacent articulating segment;positioning the adjustable ring replica at or near a patient's nativemitral valve or tricuspid valve annulus; adjusting the ring size of theadjustable ring replica using the actuator until an outer surfacecontacts the valve annulus; and determining an appropriate ring size ofprosthetic annuloplasty ring for the valve annulus.
 9. The methodaccording to claim 8, wherein the sizing device further includes atleast one elongated member coupled to the actuator in the handle andextending along the shaft to the annuloplasty ring replica, theelongated member being configured, when actuated, to pivot thearticulating segments so as to adjust the ring size of the annuloplastyring replica to a plurality of different ring sizes.
 10. The methodaccording to claim 9, wherein the shaft has a hollow bore and the atleast one elongated member comprises a flexible tension member thatconnects to the actuator, passes through the hollow bore, and extendsthrough aligned tension wire channels in the plurality of articulatingsegments, wherein tension on the flexible tension member pivots thearticulating segments with respect to one another to adjust the ringsize of the annuloplasty ring replica.
 11. The method according to claim10, wherein the annuloplasty ring replica comprises a backbone segmentcoupled to the shaft including a first backbone end and a secondbackbone end opposite the first backbone end, wherein a first pluralityof the articulating segments serially coupled to one another extend inan elongated manner from the first backbone end to the first free end ofthe annuloplasty ring replica, and wherein a second plurality of thearticulating segments serially coupled to one another extend in anelongated manner from the second backbone end to the second free end ofthe annuloplasty ring replica.
 12. The method according to claim 10,wherein the annuloplasty ring replica further includes a plurality ofaligned extension wire channels in a plurality of articulating segmentsand a flexible extension wire extending therethrough that biases theannuloplasty ring replica to a maximum ring size, wherein tension on theflexible tension wire reduces the ring size of the annuloplasty ringreplica against the bias of the flexible extension wire.
 13. The methodaccording to claim 8, wherein the shaft is malleable and couples to theannuloplasty ring replica with a swivel joint, and the step ofpositioning includes bending the handle and/or re-orienting theannuloplasty ring replica relative to the handle.
 14. The methodaccording to claim 8, further comprising a display on the handleconfigured to provide the ring size of annuloplasty ring thatcorresponds to incremental ring sizes of the annuloplasty ring replica,wherein the step of determining includes observing the display when theadjustable ring replica contacts the valve annulus.
 15. The methodaccording to claim 8, wherein a proportional shape of the annuloplastyring replica also changes for different ring sizes.
 16. The methodaccording to claim 15, wherein the annuloplasty ring replica is moreD-shaped for smaller ring sizes and more circular for larger ring sizes.17. The method according to claim 15, wherein the shaft has a hollowbore and a flexible tension member connects to the actuator, passesthrough the hollow bore, and extends through aligned channels in aplurality of articulating segments defining an arc of the annuloplastyring replica, wherein tension on the flexible tension member pivots thearticulating segments with respect to one another to reduce the ringsize of the annuloplasty ring replica, and wherein the channels inadjacent articulating segments are in different locations relative to apivot point to cause the proportional shape of the annuloplasty ringreplica change for different ring sizes.
 18. A method for sizing a heartvalve annulus, comprising: preparing a sizing device including aproximal handle having an actuator, a shaft coupled to and extending ina distal direction from the handle, a generally C-shaped annuloplastyring replica having a first free end and a second free end and coupledto a distal end of the shaft configured to be adjusted to a plurality ofdifferent ring sizes, wherein the annuloplasty ring replica is elongatedand defines a shape of the annulus being sized and is biased to amaximum ring size, wherein a proportional shape of the annuloplasty ringreplica also changes for different ring sizes, and wherein the shaft hasa hollow bore and a flexible tension member connects to the actuator,passes through the hollow bore, and extends through aligned channels ina plurality of articulating segments defining an arc of the annuloplastyring replica, wherein tension on the flexible tension member pivots thearticulating segments with respect to one another to reduce the ringsize of the annuloplasty ring replica, and wherein the channels inadjacent articulating segments are in different locations relative to apivot point to cause the proportional shape of the annuloplasty ringreplica change for ring different sizes; reducing the size of theadjustable ring replica to less than the maximum ring size using theactuator; positioning the adjustable ring replica at or near a patient'snative mitral valve or tricuspid valve annulus; increasing the ring sizeof the adjustable ring replica using the actuator until an outer surfacecontacts the valve annulus; and determining an appropriate ring size ofprosthetic annuloplasty ring for the valve annulus.
 19. The methodaccording to claim 18, wherein the shaft is malleable and couples to theannuloplasty ring replica with a swivel joint, and the step ofpositioning includes bending the handle and/or re-orienting theannuloplasty ring replica relative to the handle.
 20. The methodaccording to claim 18, further comprising a display on the handleconfigured to provide the ring size of annuloplasty ring thatcorresponds to incremental ring sizes of the annuloplasty ring replica,wherein the step of determining includes observing the display when theadjustable ring replica contacts the valve annulus.
 21. The methodaccording to claim 18, wherein the annuloplasty ring replica is moreD-shaped for smaller ring sizes and more circular for larger ring sizes.